Pharmacists and Industry: Guidelines for Ethical Interactions

American College of Clinical Pharmacy

Disclosures

Pharmacotherapy. 2008;28(3):410-420. 

In This Article

Guideline 2

Pharmacists should not solicit or accept gifts from industry that might influence or appear to influence objectivity, independence, or fairness in clinical and professional judgment.

The most contentious issue that sparks discussion about the appropriateness of behavior between industry and health care professionals is gifts. Gifts include monetary remuneration, as well as attendance at social events, hospitality, trips, acceptance of material items, and subsidies in any form. Many health professionals continue to believe that industry gifts do not influence their behavior, despite mounting evidence to the contrary.[10,11,12,13,14,15] Despite the recent publication of multiple guidelines,[2,3,4,5] numerous articles in medicine,[12,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29] nursing,[30] dental,[31] and pharmacy[32,33] literature continue to document the ethical dilemma associated with industry gifts to health care professionals. Individual approaches and recommendations from the literature range from complete avoidance now voiced by many individuals and organizations,[12,14,18,19,26,27,28,34,35] through a gradient of acceptance based on factors such as type of gift or cost.[20,36,37]

The ACCP suggests that, when confronted with ethical dilemmas regarding gifts, pharmacists should exercise sound and practical judgment. The acceptance of gifts that influence or even appear to influence objectivity, independence, or fairness in clinical and professional judgment constitutes a conflict of interest. Gifts that are not directly beneficial to patient care, education, or research should not be accepted; some argue that this applies to even small gifts, such as pens, pads, and paper-weights.[12,14,18,21,34] In addition, the following points should be considered before accepting any gift:

  • Whenever a gift is offered, ask yourself what the purpose of the gift is and does the gift truly benefit your patients in some manner. Social scientists caution that acceptance of a gift, even one of minor value, obligates the recipient to reciprocate in a like manner.[13,14]

  • The American College of Physicians[36] suggests that, as an informal measure of the propriety of accepting a gift from industry, the following questions be addressed openly and reasonably: What would my patients think about this arrangement? What is the purpose of the industry offer? What would my colleagues think about this offer?

  • Individuals may not appreciate their own inability to assess the potential for conflicts of interest. In a survey of medical residents, 61% of respondents described themselves as not being vulnerable to the influences of industry marketing efforts, although only 16% had the same high regard for their peers.[38] Although a similar study has not been conducted with pharmacists, there is little reason to suspect the outcome would differ. Because ethics deals with perception, the risk for underestimating the potential for conflicts of interest is always present.

  • Despite physicians' confidence that industry interactions have no effect on their behavior, results from numerous studies contradict that belief. As summarized in a comprehensive review of the studies evaluating the impact of industry interaction on physician behavior published in 2000, a strong correlation does exist between industry benefits and positive product endorsement, including influences on prescribing practices, formulary choices, and assessment of information provided by sales representatives.[10] Pharmacists would likely espouse similar sentiments.

In 2002, the PhRMA adopted a voluntary code to guide interactions between member companies and health care professionals.[2] The issue of gifts is pervasive throughout the code and includes the following guidance specific to gift giving: "No grants, scholarships, subsidies, support, consulting contracts, or educational or practice-related items should be provided or offered to a health care professional in exchange for prescribing products or for a commitment to continue prescribing products. Nothing should be offered or provided in a manner or on conditions that would interfere with the independence of a health care professional's prescribing practice." The following year, the Department of Health and Human Services OIG published their Compliance Program Guidance for Pharmaceutical Manufacturers.[3] The OIG guidance asserts that gifts, entertainment, and personal service compensation "have a high potential for fraud and abuse and, historically, have generated a substantial number of antikickback convictions." The document then notes that compliance with the PhRMA code "will substantially reduce the risk of fraud and abuse." It should be noted that both the PhRMA and OIG guidelines are self-regulatory, with no complaints procedure or sanctions for noncompliance outlined when violations are identified.[15,39] Nonetheless, the pharmaceutical industry in general reacted to both sets of guidelines by implementing new procedures for health care professional interactions, including the development and implementation of compliance programs.[15,39] In addition, several states have enacted legislation that mandates disclosure of payments made to health care professionals by pharmaceutical companies.[15,17,39] Unfortunately, preliminary inspection of state records after legislation was enacted in the states of Vermont and Minnesota revealed a large number of such payments still exceeding the $100 limit.[40,41]

Appropriate Gifts (per the PhRMA Code)

Gifts of a minimal (< $100) value (e.g., pens, pads, cups, and paperweights) are acceptable, although any potential for undue influence must always be considered. Educational materials such as slides, patient information guides, monographs, or books are acceptable gifts, as long as they promote objective and scientific knowledge that will benefit patient care. Although these types of gifts may be acceptable under the PhRMA code, the pharmacist must be cognizant of the potential for lack of completeness or bias in the content of material supplied by the sponsor. The use of these materials must be within the full discretion of the pharmacist.

Industry-sponsored activities are considered gifts and must be no more than modest in scope (e.g., a meal without entertainment or recreational event). Social activities should only be associated with continuing education events. Reimbursement of travel, lodging, and dining expenses, and an appropriate honorarium are acceptable for acting as a consultant, expert, or specialist. (A consultant, expert, or specialist has special knowledge, experiences, or functions within a health care system or with drug products, diseases, or patient care that are of significant value to industry to assist with their research, patient care, education, or marketing goals.) Reimbursement and an honorarium are also acceptable for providing a service (including a wide range of activities, such as speaking and moderating educational programs, administrating clinical, pharmacoeconomics, or other research studies, evaluating drug utilization reviews, and serving on advisory boards, expert panels, or focus groups) and attending an investigator (training) meeting. An educational grant may be used to lower the overall registration fee for all meeting participants.

Inappropriate Gifts (per the PhRMA Code)

The temporal relationship of any gift, even if minimal, to key decision-makers (e.g., those involved in formulary product decisions), consultants, experts, and specialists is a major component in determining the potential for undue influence of the gift. Any cash payment not associated with provision of a service should be considered an unacceptable gift. Expensive gifts are never appropriate. Invitations to social events not associated with educational events should not be accepted. Provision of entertainment by industry is also not acceptable. Items intended for personal benefit (such as floral arrangements, artwork, music CDs, or tickets to a sporting event) should not be accepted by pharmacists.

Prepaid travel to an industry-sponsored symposium and lodging for solely attending such a symposium are considered expensive gifts and are unacceptable. Pharmacists should not accept gifts, monetary or otherwise, as reimbursement for their professional time for solely attending meetings. In addition, pharmacists should not accept the cost of meeting registration. Travel and related expenses to visit a company should be associated with a service being provided; otherwise, they are considered expensive gifts. As a meeting attendee, pharmacists should not accept donation of money or gifts to a charity in lieu of payment; this should be considered the same as a direct payment.

The acceptance of any (even if modest) gift or compensation, such as research grants, in conjunction with drug purchases is not acceptable. Pharmacists should never accept gifts or any compensation from industry based on clinical practices involving any recommendations (e.g., formulary decisions, product choices for patients, or dispensing practices). Even unrestricted educational or research grants given in close proximity to key decisions or recommendations may appear to be undue influence and should be considered unacceptable.

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